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NCT02386605 · ClinicalTrials.gov registry record · NA

Motivational Negative Symptoms in Schizophrenia: Intervention and Biomarkers

A NA study, sponsored by VA Office of Research and Development.

Completed
Registry status
NA
Development phase
99
Enrollment target

NCT02386605: Completed NA study, sponsored by VA Office of Research and Development.

NCT02386605 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 99 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT02386605, a NA study, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
NA
Development phase
99 participants
Enrollment target

Study Summary

Negative symptoms significantly interfere with daily functioning among individuals with schizophrenia. They are strongly related to functional impairments \[1\] and contribute to the poor community outcomes of Veterans with schizophrenia. Motivational negative symptoms interfere with obtaining and maintaining employment \[2\], forming social relationships\[3\] and living independently \[4\]. Developing treatments to effectively reduce negative symptoms is important to achieve improvements in daily functioning. Recent empirical studies report that psychosocial interventions for negative symptoms can have a moderate to large effect size on community functioning and negative symptom severity. However, the treatments that have been utilized so far are either cognitive-behavioral therapy interventions that require over a year of weekly individual sessions and thus are very resource- and time-intensive, or they are skills-training groups that do not address any of the cognitive and motivational aspects of negative symptoms. Although group treatments are increasingly hailed as the gold standard for schizophrenia, there is currently no group intervention explicitly for motivational negative symptoms and functional deficits. Furthermore, treatment development and clinical trials are increasingly reliant on neurophysiological measures of clinical severity and treatment response and so far there are not identified negative symptom biomarkers. The current CDA proposal will test a group-based treatment based on established motivational enhancement (MI) techniques, augmented with cognitive-behavioral approaches, compared to an active control group treatment, for improving motivational negative symptoms in Veterans with schizophrenia. I will assess the efficacy of MI with measures from two outcome domains: 1) negative symptoms (clinical ratings) and 2) functional outcomes (real-world improvements in social, instrumental, and independent living). I will assess the relationship bet

Primary Outcome

This scale is a 43-item report of a patient's behavior and functioning across the following domains: physical functioning (e.g., vision, hearing), personal care skills (e.g., eating, grooming), interpersonal skills (e.g., initiating, accepting, and maintaining social contacts; effectively communicating), social acceptability (e.g., absence of verbal and physical abuse, absence of repetitive behaviors), community activities (e.g., shopping, using the telephone, paying bills, use of leisure time,

Interventions

  • BEHAVIORAL Motivational Interviewing and Cognitive Behavioral Therapy
  • BEHAVIORAL Relaxation Skills

Trial Details

FieldValue
Enrollment Target 99 participants
Start Date 2016-03-28
Est. Completion 2020-06-30
Phase NA
VA Office of Research and Development

1,668 total trials

What the finished NCT02386605 record still lists

NCT02386605 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 2 interventions - of which Motivational Interviewing and Cognitive Behavioral Therapy is the first listed.

NCT02386605 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02386605 about?

NCT02386605 is a clinical study titled "Motivational Negative Symptoms in Schizophrenia: Intervention and Biomarkers". Negative symptoms significantly interfere with daily functioning among individuals with schizophrenia. They are strongly related to functional impairments \[1\] and contribute to the poor community outcomes of Veterans with schizophrenia. Motivational negative symptoms interfere with obtaining and m...

What is the current status of trial NCT02386605?

This trial is currently completed. It is a NA study. The enrollment target is 99 participants. The study started on 2016-03-28. Estimated completion is 2020-06-30.

What interventions are being tested in trial NCT02386605?

The interventions under investigation include: Motivational Interviewing and Cognitive Behavioral Therapy (BEHAVIORAL), Relaxation Skills (BEHAVIORAL).

Who is sponsoring clinical trial NCT02386605?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02386605's enrollment target sits among peer trials

99 920th of 2000 higher than 1,079 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02386605, the US trial registry maintained by the National Library of Medicine. NCT02386605 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.